Quality - QA CTO Label Specialist

PURPOSE AND SCOPE OF POSITION:
The Quality Assurance Label Control Specialist at the S-12 Cell Therapy manufacturing facility is
responsible for supporting site Label Control activities at S-12 in accordance with Client policies,
standards, procedures and Global cGMPs . Functional responsibilities include performing in process and drug product label printing activities; ensuring accurate and timely issuance of
labels for manufacturing and packaging labeling activities for Cell Therapy Development and
Operations ( CTDO ).
The Quality Assurance Label Control organization is responsible for the establishment,
maintenance and continuous improvement of the clinical and commercial label control process,
procedures, and responsibilities for achieving quality policies and objectives. This organization
supports the S-12 facility to ensure patient safety, regulatory requirements and improve its
effectiveness and efficiency on a continuous basis.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Must have knowledge and experience with GMP, Quality, and compliance.
Able to write and review technical reports with clarity and brevity; provides guidance to other
team members in technical writing skills.
Requires moderate direction to complete more complex tasks; completes routing tasks with
little or no supervision.
Must be time organized and possess an independent mindset.
Good understanding of electronic document management and manufacturing execution
systems.
Has advanced computer skills to increase department's productivity, as well as broadening
technical and scientific knowledge.
Confident in making decisions for non-routine issues.
Routinely recognizes and addresses quality opportunities to improve overall process/project
efficiencies.
Proposes solutions for complex issues and works with management to resolve. Follows
established procedures and performs work as assigned.
Builds relationships and effectively communicates internally within the function and with
internal and external cross-functional teams. Interacts with internal and external cross functional teams. Represents department in internal and external cross-functional teams.
Contributes to goals within the work group.
Able to recognize conflict and notify management with proposed recommendations for
resolution.
Able to prepare written communications and communicate problems to management with
clarity and accuracy.
Able to produce data reports with precision.
Able to multi-task.
Able to support internal and health authority inspections of facility

by Jobble